> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-ii-study-of-an-anti-her3-antibody-hmbd-001-with-026a36f4-4a47-44e5-942f-01f081708ee9 > Record changed: 2026-10-13 # A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers NCT05910827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) Participants 398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) Lead sponsor Hummingbird Bioscience Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) Start date 2024-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Title and summary **Summary** This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Short title** A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Official title** A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **First posted** 2023-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Registry last updated** 2026-05-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Start date** 2024-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Size and sites **Participants** 398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Planned participants** 398 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Lead sponsor** Hummingbird Bioscience Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Identifiers **Registry ID** NCT05910827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **ClinicalTrials.gov ID** NCT05910827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Outcomes ### Primary outcomes 1. Incidence and Nature of Adverse Events (AEs) Timeframe: From the time the Informed Consent Form (ICF) is signed until 30 days after last dose of study treatment Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, vital signs and ECG results per NCI CTCAE V5.0 Incidence of dose interruptions and modifications An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered to be related to the study treatment 2. Number of participants with dose-limiting toxicities (DLTs) - applicable to part A Timeframe: From date of enrollment (first dosing) until the end of Cycle 1 (each cycle is 21 days) DLTs will be assessed in the dose escalation cohorts and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment 3. Six months progression-free survival (PFS) - applicable to part B Timeframe: From date of enrollment (first dosing) until disease progression or death, assessed up to 6 months Number of participants achieving progression-free survival (PFS) at 6 months ### Secondary outcomes 1. Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 Timeframe: From date of enrollment (first dosing) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months The ORR is defined as the proportion of subjects with confirmed Complete Response (CR) or confirmed Partial Response (PR), based on RECIST Version 1.1 2. HMBD-001 serum concentration-time profile and derived PK parameters Timeframe: From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months 3. HMBD-001 Immunogenicity Profile Timeframe: From date of enrollment (first dosing) until date of end of treatment from any cause, including multiple treatment cycles (each cycle is 21 days), assessed up to 48 months Number and percentage of participants who develop detectable ADAs Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Ability to understand and be willing to sign an informed consent form - Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is > 18 years of age) - Eastern Cooperative Oncology Group (ECOG) status of 0 to 1 - Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable - Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy, - Have an estimated life expectancy of at least 3 months - Participants must be willing to provide a fresh tumor biopsy sample - Have adequate organ function - Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal - Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion ### Exclusion criteria - Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C - Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation - Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade >2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the study results e.g., alopecia - Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment - Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline - Evidence of abnormal cardiac function - History of uncontrolled allergic reactions and/or known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into - Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer - Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment - Known Human Immunodeficiency Virus (HIV) infection - Active hepatitis B or hepatitis C infection - Pregnant or breast feeding - COVID 19 infection within 3 months prior to the first dose of the study drug - COVID 19 vaccination within 14 days prior to the first dose of the study drug - Treatment with strong inhibitors or inducers of CYP3A4 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Sites - GenesisCare North ShoreSydney, AustraliaWithdrawn - Westmead HospitalWestmead, AustraliaRecruiting - ICON Cancer Centre South BrisbaneBrisbane, AustraliaWithdrawn - Greenslopes Private HospitalGreenslopes, AustraliaRecruiting - Southern Oncology Clinical Research UnitAdelaide, AustraliaRecruiting - Peninsula & South Eastern Haematology and Oncology GroupFrankston, AustraliaRecruiting - Cabrini HealthMalvern, AustraliaWithdrawn - Linear Clinical ResearchPerth, AustraliaRecruiting - The Institute of Oncology, ARENSIA Exploratory Medicine Phase I UnitChisinau, MoldovaRecruiting - National Cancer Centre SingaporeSingapore, SingaporeRecruiting - Tan Tock Seng HospitalSingapore, SingaporeRecruiting - Chungbuk National University HospitalCheongju-si, South KoreaRecruiting - CHA Bundang Medical Center, CHA UniversitySeongnam-si, South KoreaRecruiting - Korea University Anam HospitalSeoul, South KoreaRecruiting - Severance HospitalSeoul, South KoreaRecruiting - The Catholic University of Korea St. Vincent's HospitalSuwon, South KoreaRecruiting - Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanRecruiting - National Cheng Kung University HospitalTainan, TaiwanRecruiting - Taipei Medical University - Shuang Ho HospitalTaipei, TaiwanRecruiting - Taipei Veterans General HospitalTaipei, TaiwanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05910827) ## Related records ### Drugs (3) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Nezutatug](https://trialight.com/data/asset/nezutatug-7e36e8b4-5091-4870-bbbe-74a343c19d0d.md) ### Collaborators (1) - Merck KGaA, Darmstadt, Germany ### Lead sponsors (1) - [Hummingbird Bioscience](https://trialight.com/data/company/hummingbird-bioscience-a4fc5b85-2cc9-4129-8cba-80d3e1165264.md) ### Conditions (7) - [Cervical squamous cell carcinoma](https://trialight.com/data/condition/cervical-squamous-cell-carcinoma-cf19f5cb-f41b-58a1-a675-3d881c3a62a2.md) - [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Nasopharyngeal carcinoma](https://trialight.com/data/condition/nasopharyngeal-carcinoma-9ead4a97-f794-5dda-b62e-20f8ca202f89.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Skin squamous cell carcinoma](https://trialight.com/data/condition/skin-squamous-cell-carcinoma-29047668-8486-533e-ac8b-779eed01f018.md) - [Squamous cell carcinoma](https://trialight.com/data/condition/squamous-cell-carcinoma-44944de3-3c1f-5714-9da2-a28db7d896c2.md) ### Targets (16) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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